Views: 0 Author: Site Editor Publish Time: 2021-08-29 Origin: Site
Construction of production facilities
Adhering to the working attitude of "high quality, pursuit of excellence and continuous refinement", relying on the high-quality resource sharing of Nanjing biomedical platform and quality production management system, the company continues to build a technical team, and has built (including under construction) school enterprise cooperation platform, Graduate mobile station and other sustainable development projects. The production and research base of phase I project is 3000 square meters and the 100000 level clean plant area is 2000 square meters. According to the design requirements of GMP oral solid clean plant, the possible influencing factors of personnel, environment and materials on the products are strictly controlled; The factory has introduced a full-automatic filling and sealing linkage line to ensure the production of high-quality products; The whole process risk management mode is adopted in the production quality process to continuously track and improve the influencing factors of quality risk.
The design plan of phase II project (under construction) is 20000 square meters, 10000 square meters of 100000 level clean plant area and 2000 square meters of 10000 level clean plant area. The whole process unmanned production mode of real-time production is introduced, and the scale of production line is further upgraded to enhance its core competitiveness while improving its innovation ability and product quality, Join hands with customers to create a new blueprint for the development of molecular diagnosis industry.
In order to break the monopoly of foreign leading brands on key raw materials and core technologies, and ensure to provide customers with high-quality products and services, the company is based on its independent research and development platform, and systematically and rigorously carries out effective quality control, from the introduction of raw materials to the sale of the warehouse. Layer check.The company has a standardized and traceable SOP system and has passed ISO9001 and ISO13485 quality management system certification.Strictly select domestic and foreign production raw material suppliers, adopt high-quality production raw materials, carry out strict quality control and monitoring throughout the production process, and operate in compliance with the ISO13485 quality management system to effectively ensure the stability of product quality.